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EC number: 267-012-8 | CAS number: 67762-34-9 This substance is identified by SDA Substance Name: C8-C18 and C18 unsaturated alkyl carboxylic acid zinc salt and SDA Reporting Number: 01-006-09.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Zinc dioctanoate
- EC Number:
- 209-156-6
- EC Name:
- Zinc dioctanoate
- Cas Number:
- 557-09-5
- Molecular formula:
- C16H30O4Zn
- IUPAC Name:
- zinc(II) octanoate
- Reference substance name:
- Zinc decanoate
- EC Number:
- 235-909-3
- EC Name:
- Zinc decanoate
- Molecular formula:
- C10H20O2.1/2Zn
- IUPAC Name:
- zinc(II) decanoate
- Reference substance name:
- Zinc dilaurate
- EC Number:
- 219-518-5
- EC Name:
- Zinc dilaurate
- Cas Number:
- 2452-01-9
- Molecular formula:
- C12H24O2.1/2Zn
- IUPAC Name:
- zinc(II) dodecanoate
- Reference substance name:
- Zinc dimyristate
- EC Number:
- 240-369-7
- EC Name:
- Zinc dimyristate
- Cas Number:
- 16260-27-8
- Molecular formula:
- C28H54O4Zn
- IUPAC Name:
- zinc(II) tetradecanoate
- Reference substance name:
- Zinc dipalmitate
- EC Number:
- 225-652-5
- EC Name:
- Zinc dipalmitate
- Cas Number:
- 4991-47-3
- Molecular formula:
- C16H32O2.1/2Zn
- IUPAC Name:
- zinc(II) hexadecanoate
- Reference substance name:
- Zinc distearate
- EC Number:
- 209-151-9
- EC Name:
- Zinc distearate
- Cas Number:
- 557-05-1
- Molecular formula:
- C18H36O2.1/2Zn
- IUPAC Name:
- zinc(II) octadecanoate
- Reference substance name:
- Zinc dioleate
- EC Number:
- 209-154-5
- EC Name:
- Zinc dioleate
- Cas Number:
- 557-07-3
- Molecular formula:
- C18H34O2.1/2Zn
- IUPAC Name:
- zinc(II) 9-octadecenoate
- Reference substance name:
- Zinc dilinoleate
- EC Number:
- 235-870-2
- EC Name:
- Zinc dilinoleate
- Cas Number:
- 13014-44-3
- Molecular formula:
- C36H62O4Zn
- IUPAC Name:
- zinc(II) 9,12-octadecdienoate
- Test material form:
- solid: bulk
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain : NSam:Sprague-Dawley Rat
Microbiological grade : Specific Pathogen Free(SPF)
Sex : Female(nulliparous and non-pregnant)
Breeder : Samtako Bio Korea
(105, Seorang-ro, Osan-si, Gyeonggi-do, Republic of Korea)
Supplier : Young Bio Co., Ltd.
(388, Dunchon-daero, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea)
Step Age (week old) Sex Number of animals
At acquisition 7 Female 10
Range-finding study
G1(step 1) 8 Female 1
G2(step 2) 8 Female 1
G3(step 3) 9 Female 1
Main study
G4(step 1) 9 Female 2
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- 3.2. Administration of Test Substance
3.2.1. Justification for route of administration
The dermal route was selected to investigate the dermal toxicity of test substance.
3.2.2. Dose frequency and duration
Single dermal administration of continuous exposure for 24 hours.
3.2.3. Administration
The dose volume was calculated on the basis of body weight on the administration day.
3.2.4. Method
The test substance was spread on the porous gauze and attached to the administration area.
Non-irritating tape(Tegarderm, 3M) and elastic bandages(Coban, 3M) were used to prevent the loss of test substance and to have the test substance in good contact with the skin continuously for 24 hours.
After the 24-hour exposure of the test substance, the gauze, non-irritating tape, and elastic bandages were removed and residual test substance was removed using sterilized distilled water. - Duration of exposure:
- 24 hours
- Doses:
- G1 (Range-finding study step 1)
The starting dose level was selected as 200 mg/kg body weight (b.w.) due to a lack of toxicity information of the test substance.
G2 (Range-finding study step 2)
As a result of observation after the step 1 administration(before administration of the step 2), no dead animal was observed. Thus, the dose level was selected as 1,000 mg/kg b.w..
G3 (Range-finding study step 3)
As a result of observation after the step 2 administration(before administration of the step 3), no dead animal was observed. Thus, the dose level was selected as 2,000 mg/kg b.w..
G4 (Main study step 1)
As a result of observation after the step 3 administration, no dead animals were observed in all does levels of range-finding study. Thus, the starting dose level of the main study was selected as 2,000 mg/kg b.w.. - No. of animals per sex per dose:
- range-rinding study: 1
main study: 2 - Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in this study.
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- In all administration groups of the range-finding study and main study, body weight loss was observed on day 1 after the administration. However, body weight gains were noted on day 3, 7, and 14 measurements.
- Gross pathology:
- No gross lesions related to the test substance administration were observed in all animals of the rangefinding study and the main study.
- Other findings:
- As a result of observing the site of administration at each step, very slight erythema(score: 1) was observed at 0 hour and 24 hours, and slight erythema(score: 2) was observed at 48 hours and 72 hours after removing the test substance in the range-finding study(3 step).
In the main study(step 1), slight erythema(score: 2) was observed in 2 animals at 24 and 48 hours. 1 animal recovered at 72 hours, but slight erythema(score: 2) was observed in the other animal at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- This study was conducted to confirm the GHS(Globally Harmonized System of Classification and Labelling
of Chemicals) category based on the acute toxicity of the test substance, Fatty acids, C8-18 and C18-unsatd.,
zinc salts, following a single dermal administration to female Sprague-Dawley rats. In the range-finding
study, the dose levels were set as 200 mg/kg b.w(step 1), 1,000 mg/kg b.w.(step 2) and 2,000 mg/kg b.w.(step
3). In the main study, the dose level was set as 2,000 mg/kg b.w.(step 1).
The test substance was administered to one animal in each step in the range-finding study, and two animals
in the main study. Mortality, clinical signs and body weights were observed for 14 days and at the end of the
14-day observation period for each step, gross necropsy was performed.
No mortality was observed in this study.
Erythema and exfoliation observed in the range-finding study(3 step) and main study(1 step) are determined
by the influence of the test substance.
In all administration groups of the range-finding study and main study, body weight loss was observed on
day 1 after the administration. The body weight loss observed on day 1 in all administration groups are
considered to be a temporary phenomenon caused by continuously fixing with the elastic bandage for 24
hours during the administration procedure.
No gross lesions related to the test substance administration were observed in all animals of the range-finding
study and the main study.
As a result, the test substance, Fatty acids, C8-18 and C18-unsatd., zinc salts is confirmed as GHS Category
5/Unclassified in this study.
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